EXCEL: PCI noninferior to CABG at 3 years in left main disease
WASHINGTON — Treatment of patients with left main CAD and low or intermediate SYNTAX scores with everolimus-eluting stents resulted in similar rates of the primary endpoint of death, stroke or MI at 3 years compared with CABG, Gregg W. Stone, MD, reported at TCT 2016.
Anticipated results of the EXCEL trial showed that the rate of the primary endpoint was 15.4% among patients who underwent PCI with EES vs. 14.7% among patients who underwent CABG at 3 years (0.7 percentage point difference; upper 97.5% confidence limit, 4 percentage points; P = .02 for noninferiority; HR = 1; 95% CI, 0.79-1.26; P for superiority = .98).
“PCI may be considered an acceptable, or even a preferred, alternative to bypass surgery in selective patients with left main CAD meeting the criteria of this trial, although that is a decision that should be made by the local heart team, considering the patient’s individual circumstances and preference,” Stone, from NewYork Presbyterian Hospital/Columbia University Medical Center and Cardiology Today’s Intervention Editorial Board member, said during a press conference at TCT 2016.
PCI vs. CABG
Researchers for the EXCEL trial randomly assigned 1,905 patients to undergo PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (EES; n = 948) or CABG (n = 957). Patients were enrolled at 126 sites in 17 countries from September 2010 to March 2014. The researchers assessed anatomic complexity, which was defined as a SYNTAX score 32. At baseline, mean SYNTAX score was 20 in both groups when measured at the site and 26 when measured by the core lab.
Secondary endpoint analysis showed that the rate of death, stroke or MI at 30 days was 4.9% among patients assigned EES vs. 7.9% among patients assigned CABG (P for noninferiority < .001; P = .008 for superiority). However, the rate of death, stroke, MI or ischemia-driven revascularization at 3 years was 23.1% with EES vs. 19.1% with CABG (P for noninferiority = .01; P for superiority = .1).
Major periprocedural adverse events at 30 days were less frequent in the PCI group (8.1% vs. 23%; P < .001).
Both ‘reasonable options’
During a press conference at TCT 2016, Michael J. Mack, MD, from the Heart Hospital Baylor Plano, Texas, acknowledged that “any trial that randomizes a surgery vs. less-invasive therapy is very difficult to execute.” The data show that both PCI and CABG are “reasonable options” in this patient population, he said.
Dean J. Kereiakes, MD, from The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, and Cardiology Today’s Intervention Editorial Board member, said EXCEL is “a practice-changing trial that will inform our current guidelines.”
The EXCEL researchers noted that “longer-term follow-up is required to examine whether additional differences between PCI and CABG emerge over time; 5-year follow-up is currently being undertaken.”
Eugene Braunwald, MD, from the TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital and Harvard Medical School, discussed the findings in a related editorial in NEJM. “The take-home message from the EXCEL trial is that the majority of patients with unprotected left main coronary artery disease, which was a very serious, life-shortening and disabling condition early in my professional lifetime, can now be managed equally well by mean of two strategies of revascularization if carried out by expert, experienced teams such as those participating in the EXCEL trial.
“The outcomes of shorter hospital stay, greater early safety benefit, and more rapid recovery and return to normal activity favor PCI over CABG. However, despite the similar results with respective to the primary endpoint of death, stroke or MI at 3 years, it should be noted that the PCI group exhibited a greater increase in these events between 30 days and 3 years than did the CABG group. Therefore, it is reassuring that the EXCEL investigators plan further follow-up of these patients,” Braunwald, a member of the Cardiology Today Editorial Board, wrote. – by Dave Quaile
Stone GW, et al. Late-Breaking Clinical Trials 2. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2016; Washington, D.C.
Disclosure: Braunwald and Mack report no relevant financial disclosures. Kereiakes reports receiving consultant fees/honoraria/speaker’s fees from Abbott Vascular, Boston Scientific, Caliber Therapeutics, Harvard Clinical Research Institute, Micell Technologies, Sino Medical Sciences Technology and Svelte Medical Systems, and equity in Ablative Solutions. Stone reports financial relationships with multiple pharmaceutical and device companies. Please see the full study for a list of the other researchers’ relevant financial disclosures.